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| Product NDC Code | 63029-311 | ||||||||||||||
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| Drug Name | Ecotrin |
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| Type | Brand | ||||||||||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||
| Dosage Form | TABLET, COATED | ||||||||||||||
| RxCUI drug identifier | 308416, 1189781 |
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| Application Number | M013 | ||||||||||||||
| Labeler Name | Medtech Products Inc. | ||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Aspirin (NSAID) *81mg *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions drink a full glass of water with each dose adults and children 12 years and over : take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years : do not use unless directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients black iron oxide, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor aches and pain due to: headache minor arthritis pain toothache muscle pain menstrual pain colds or as recommended by your doctor
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Ecotrin Aspirin ASPIRIN ASPIRIN FERROSOFERRIC OXIDE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED Polyvinyl Acetate Phthalate PROPYLENE GLYCOL SODIUM ALGINATE SODIUM BICARBONATE STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE Ecotrin;Low
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Ecotrin ® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 45 Tablets PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 45 Tablets
PRINCIPAL DISPLAY PANEL Ecotrin ® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 150 Tablets PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 150 Tablets
PRINCIPAL DISPLAY PANEL Ecotrin ® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 365 Tablets PRINCIPAL DISPLAY PANEL Ecotrin® Safety Coated Aspirin (NSAID) Pain Reliever 81 mg Low Strength 365 Tablets
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug for ▪ gout ▪ diabetes ▪arthritis
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 25°C (77°F); exclusions permitted between 15°C-30°C (59°F-86°F) see end flap for expiration date and lot number avoid excessive heat and humidity
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-255-5202 Ecotrin.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. any new symptoms appear ringing in the ears or a loss of hearing occurs. pain gets worse or lasts more than 10 days redness or swelling is present. These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Reye’s syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older take more or for a longer time than directed have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for ▪ gout ▪ diabetes ▪arthritis Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. any new symptoms appear ringing in the ears or a loss of hearing occurs. pain gets worse or lasts more than 10 days redness or swelling is present. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API